The third-party 510(k) review process was an emphasis in the most recent user fee negotiations and statutory changes under the FDA Reauthorization Act of 2017 (FDARA). This process has been criticized in the past for being restrictive, ineffective, and not beneficial for applicants. On January 26, 2018, FDA took its first step towards complying with the new requirements when it issued performance metrics for third-party reviewers (available here).
As discussed in our FDARA summary (available here), the types of devices has been modified. Addressing the restrictive aspect, the most significant change was that devices requiring clinical data are no longer excluded from eligibility for the program. This change has opened up the possibility of more devices, most notably IVDs, being able to undergo third-party review in the future.
FDA will issue a draft guidance regarding the factors it will use to determine whether a Class I or II device is eligible for third-party review, and the Agency will finalize the guidance within 24 months from issuance of the draft. On the same day the guidance is finalized, FDA will also publish a list of Class I and II devices eligible for third-party review. Until this new list is published, the current list of devices eligible for third-party review is still in effect. In addition, as part of the user fee negotiations, FDA agreed, by the end of 2018, to issue draft guidance regarding criteria for reaccreditation of third party reviewers and the suspension or withdrawal of accreditation of a third party.
Finally, FDA agreed to publish performance metrics regarding third-party reviewers with at least five completed submissions on the web. FDA’s published statistics for FY2018 only, meaning, at most, less than four months worth of data. There were seven third party reviewers totaling 18 510(k) submissions since October 1, 2017. Only one of the reviewers had more than five submissions during this timeframe. This report was issued on January 26, but it is not clear when data collection for the report ceased. This sparse data set is of little to no use. Presumably, the next data set will be more meaningful.
The user fee commitment did not specify a timeframe for analysis. It seems odd that FDA selected FY2018. It provides very limited information because it is such a short time frame. The utility of the report is, accordingly, limited. We look forward to FDA completing its other required tasks related to the third party review process. The process certainly holds potential but has been consistent in one respect – during its two decades, it has not lived up to its expectations or potential. Perhaps these steps will help change that.
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